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GRCE FDA decision: Apr 23, 2026

Updated ·next FDA decision on the calendar
✕ COMPLETE RESPONSE LETTER

Grace Therapeutics Inc.: GTX-104 - (STRIVE-ON) · Subarachnoid hemorrhage (SAH).

Run-up into the decision (T-120 → T+5)

PDUFA 4/23/26$5.13$2.9911/6/25
Daily close, T-120 (11/6/25) through T+5. Run-up high $5.13 on 4/3/26, low $2.99 on 11/17/25 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-23
OutcomeCRL
Drug / candidateGTX-104 - (STRIVE-ON)
CompanyGrace Therapeutics Inc.
120-day run-up (T-120→T-1)+37.7%

Questions

Was GTX-104 - (STRIVE-ON) approved by the FDA?

Not in this review cycle. On April 23, 2026 the FDA issued a Complete Response Letter, declining to approve the application for GTX-104 - (STRIVE-ON) in its current form. A CRL is not final; the primary source is linked on this page.

Which company is behind GTX-104 - (STRIVE-ON)?

GTX-104 - (STRIVE-ON) is a Grace Therapeutics Inc. (GRCE) program. The FDA decision came on April 23, 2026; the company's own announcement is linked on this page.

How did GRCE stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), GRCE moved +37.7%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.